A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects
A 2:1 randomization between tivozanib in combination with mFOLFOX6 to bevacizumab in
combination with mFOLFOX6. Subjects will be stratified by origin of cancer, Lactate
Dehydrogenase (LDH) status, and number of metastatic sites.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS) based on investigator radiological tumor assessment
The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression is defined by radiological assessments by the investigators.
3 years
No
Medical Director
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
4130-CL-0201
NCT01478594
November 2011
December 2015
Name | Location |
---|---|
University of California San Diego | La Jolla, California 92093 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
NYU Cancer Institute | New York, New York 10016 |
Northwestern University | Chicago, Illinois 60611 |
Cancer Care Associates | Tulsa, Oklahoma 74136 |
Northern Utah Associates | Ogden, Utah 84403 |
St. Luke's Hospital and Health Network | Bethlehem, Pennsylvania 18015 |
Oregon Health and Science University | Portland, Oregon 97201 |
Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage, California 92270 |
University of Hawaii | Honolulu, Hawaii 96813 |
Investigative Clinical Research of Indiana, LLC | Indianapolis, Indiana 46254 |
Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
Cleveland Clinic Florida | Weston, Florida 33331 |
Horizon Oncology Research, Inc. | Lafayette, Indiana |
Banner MD Anderson Cancer Center | Gilbert, Arizona 85234 |
Genesis Cancer Center | Hot Springs, Arizona 85715 |
UC Irvine Medical Center, Division of Hematology/Oncology | Orange, California 92868 |
Mountain Blue Cancer Care Center | Wheat Ridge, Colorado 80033 |
University of Florida, Davis Cancer Center (VA) | Gainesville, Florida 32610 |
Kaiser Foundation Hospitals | Honolulu, Hawaii 96819 |
Illinios Cancer Care | Peoria, Illinois 61615 |
Associates of Oncology Hematology, P.C. | Rockville, Maryland 20850 |
University of Michigan Hospital and Health Center | Ann Arbor, Michigan 48109 |
Alamance Regional Medical Center Cancer Center | Burlington, North Carolina 27215 |
Tri Country Hematology / Oncology | Canton, Ohio 44718 |